Associate Medical Director

The Position

JOB DESCRIPTION

Seeking an MD with at least two years of industry experience to work on a late stage molecule for ulcerative colitis and Crohn’s disease. Multiple ongoing Phase 3 studies with data readouts for ulcerative colitis next year.

Cross-Functional Team Membership

Participates in the relevant Clinical Science Team (CST)

Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment to enable effective and efficient clinical development (CD) plan execution

As requested, supports the CST lead and overall team with training new CST members

May also, as appropriate, support relevant sub-teams in training new team members

Participates in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources

As needed or otherwise appropriate, assists with CD recruitment, training, and/or coaching of new or less experienced CD staff members

Global Clinical Development Planning

Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)

As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects

Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment

Can collaborate with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, regulatory, business development, commercial operations, legal, etc.

May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance. Includes reviewing Phase I protocols and providing CD input into these

Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase IIIB protocols and other information and provide CD input

Supports other CST members with development of clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)

Participates in implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs:

Supports other CST members in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients. Escalates matters, as needed, in a timely manner to his/her manager or other internal partners/stakeholders

Clinical Development Plan Implementation

Provides clinical support across all relevant studies and programs:

Participates in ongoing CST and relevant sub-team meetings, other interactions and communications

Collaborates with others in the development of the product safety profile

Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials

Represents, alongside his/her manager or others, Roche in key investigator and other external presentations, meetings and other communications

Ensures investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study

Acts as a medical monitor for assigned studies

Conducts and coordinates ongoing reviews of medical/safety data

Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such

Collaborates with other groups to ensure timely and appropriate completion of interim study reporting

Works with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes.

Develops and delivers key presentations to convey the CD perspective and provide updates on strategies, plans and other activities

Completes other special projects, as and when assigned, or otherwise requested

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements.

QUALIFICATIONS & EXPERIENCE:

M.D. with relevant medical experience in Gastroenterology, Internal Medicine, or related field

2 or more years pharma/biotech industry experience

2 or more years experience with clinical trials across Phase II – III drug development

Academic/teaching background is a plus

Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)

Experience developing product and safety profiles

Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such

Good interpersonal, verbal communication and influencing skills; can influence without authority

Strong written communication skills

Good business presentation skills; is comfortable and effective when presenting to others, internally or externally

Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally

Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy

Works well within teams and is effective in collaborating with others internally and externally

Ability to travel globally (<30%)

#LI-PDKM2

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.

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